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Active, Not Recruiting

NCT Number: NCT04107948

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Fibromyalgia Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Physical Activity Rheumatic Diseases Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH d'ANNONAY, Annonay, France

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About this study

In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining:

  • an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town)
  • therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
  • French writing and speaking
  • Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion)
  • Signature of informed consent

Exclusion criteria

  • Cardiac or respiratory diseases that contraindicate the practice of physical activity
  • Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
  • Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

Treatment and study plan

Physical activity program

Other

Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42), Haute-Loire (43) or Ardèche (07) for 2 months.

Advice and recommendations of physical activity at home

Other

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Primary outcomes

  1. physical activity

    Time frame: 12 months

    Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph

Secondary outcomes

  1. sedentary

    Time frame: 12 and 24 months

    Measure the durability of adhesion/therapeutic compliance of fibromyalgia patients based on an objective measurement of sedentary : average measured from 7 days of actimetry, Actigraph

  2. physical activity

    Time frame: 0, 1, 3, 6, 12 and 24 months

    Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph

  3. sedentary

    Time frame: 0, 1, 3, 6, 12 and 24 months

    Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph

  4. health status

    Time frame: 0, 1, 3, 6, 12 and 24 months

    measured with Patient Global Impression of Change (PGIC) : on a 7-point scale, rated from 1 for "much worse" to 7 for "much better". It is a simple and practical evaluation tool to use. The combination of the level of achievement via the Patient Global Impression of Change and the initial documentation of the patient's objectives via the shared educational assessment is a relevant and understandable approach for the patient.

  5. fatigue

    Time frame: 0, 1, 3, 6, 12 and 24 months

    assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7.

    Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5

  6. Quality of sleep

    Time frame: 0, 1, 3, 6, 12 and 24 months

    assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score.

    The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3.

    In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.

  7. Anxiety and Depression

    Time frame: 0, 1, 3, 6, 12 and 24 months

    assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.

  8. pain catastrophizing

    Time frame: 0, 1, 3, 6, 12 and 24 months

    assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time

  9. pain evaluation

    Time frame: 6 and 12 months

    assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

  10. fatigue evaluation

    Time frame: 6 and 12 months

    assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)

  11. muscle power

    Time frame: 0, 1 and 3 months

    evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

  12. muscular endurance

    Time frame: 0, 1 and 3 months

    evaluated by dynamometry on a stress platform (arms and legs).

  13. gas exchange measurement

    Time frame: 0, 1 and 3 months

    evaluated during a stress test

  14. fatigue

    Time frame: 0, 1 and 3 months

    evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex

  15. quantification of physical activity in meter-h/week

    Time frame: 0, 1, 3, 6,12 and 24 months

    evaluated by the APAQ : Adult Physical Activity Questionnaire

  16. sedentary times in hours/day

    Time frame: 0, 1, 3, 6, 12 and 24 months

    evaluated by the APAQ : Adult Physical Activity Questionnaire

  17. patient adherence

    Time frame: 6 and 12 months

    number of sessions performed

  18. Direct medical costs

    Time frame: 12 months

    consultations, examinations, hospitalizations in euros

  19. Direct non-medical costs

    Time frame: 12 and 24 months

    transport

  20. Cost of lost productivity

    Time frame: 12 and 24 months

    time not worked

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary

Acronym: FIMOUV 2

Important dates

Study start
2020
Primary completion
2025
Study completion
2031
First posted
Sep 27, 2019
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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